The National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health (NIH) is unique in having a dual role of advancing the science and public health countermeasures for a contemporary set of pathogens and diseases, as well as rapidly responding to newly emerging pathogens. Key examples include the emergence of novel seasonal and pandemic influenza strains and SARS coronavirus, as well as the profound, current example of the emergence of SARS-Cov-2. New bacterial and fungal pathogens include several Rickettsia spp, Neoehrlichia spp. And Candida auris. Perhaps more challenging for bacteria is the endless evolution of novel resistance genes and mechanisms in well established pathogens.
Strategies to confront this relentless tide include the development of novel therapeutic agents such as next generation candidates from existing classes, development of new classes, and development of new or non-traditional approaches. Few examples of truly new classes have appeared and been successful in recent years. Current enthusiasm is increasing for novel approaches such as bacteriophage therapy in the contemporary regulatory environment, as well as virulence inhibitors and alternative approaches such as antimicrobial peptides that may have an indirect mechanism of action rather than direct inhibitory action. Each of these concepts poses individual pathway development uncertainties, and NIAID is exerting substantial efforts to advance the field. In the U.S., the recognition of artificially emerging agents after 9/11was a crucial to the increased focus on countermeasure development. NIAID’s efforts, including a spectrum of special, targeted funding announcements for traditional grant and contract mechanisms, have been instrumental in paving the path forward in product development.